NCT02378220

Pharmacogenetic Testing Among Home Health Patients

A Pilot Prospective, Randomized Controlled Trial Assessing the Clinical Impact of Integrated Pharmacogenetic Testing on Selected OASIS Metrics, Re-hospitalizations and Emergency Department Visits

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Genelex Corporation · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Patients meeting eligibility criteria will be randomized into two groups, one receiving pharmacogenetic testing and the other not receiving pharmacogenetic testing. In this open-label trial, a pharmacist will make medication therapy recommendations using YouScript® Personalized Prescribing System for patients who receive genetic testing and standard drug information resources per usual for patients who do not undergo pharmacogenetic testing.

Detailed description

Both groups will be followed for 60 days. The number of re-hospitalizations and emergency department (ED) visits will be recorded as well as time to first re-hospitalization and time to first ED visit. Select Outcome and Assessment Information Set (OASIS) metrics (e.g. M1034, M1242, M1710, M1720, M1745, M2110) and Patient Health Questionnaire (PHQ)-2 will be evaluated and documented at time of admission to home health, at 30 days, and at 60 days for improvement in overall status, pain, confusion, anxiety, depression, disruptive behavior, and the need for assistance with activities of daily living (ADLs) and instrumental activities of daily living (IADLs). The number of falls will be collected as well as the proportion of YouScript® recommendations accepted by study pharmacist and passed on to clinicians and the proportion of recommendations accepted by clinicians.

Conditions

• Adverse Drug Events
• Adverse Drug Reactions
• Drug Interaction Potentiation
• Drug Metabolism, Poor, CYP2D6-RELATED
• Drug Metabolism, Poor, CYP2C19-RELATED
• Cytochrome P450 Enzyme Deficiency
• Cytochrome P450 CYP2D6 Enzyme Deficiency
• Cytochrome P450 CYP2C9 Enzyme Deficiency
• Cytochrome P450 CYP2C19 Enzyme Deficiency
• Cytochrome P450 CYP3A Enzyme Deficiency
• Poor Metabolizer Due to Cytochrome P450 CYP2C9 Variant
• Poor Metabolizer Due to Cytochrome p450 CYP2C19 Variant
• Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant

Interventions

Type	Name	Description
GENETIC	Pharmacogenetic testing	Pharmacogenetic testing via YouScript® Personalized Prescribing System

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2015-03-04
• Last updated: 2019-09-20
• Results posted: 2018-08-29

Locations

1 site across 1 country: United States